Transcranial Direct Current Stimulation to Treat Major Depressive Disorder
An Open-label, Crossover Study on Major Depressive Disorder Using Transcranial Direct Current Stimulation
1 other identifier
interventional
60
1 country
1
Brief Summary
The investigators purpose is to offer active Transcranial Direct Current Stimulation (tDCS) in patients of the investigators previous study who received either placebo or sertraline and have not responded.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 major-depressive-disorder
Started Jun 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 22, 2010
CompletedFirst Posted
Study publicly available on registry
June 24, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedDecember 6, 2011
December 1, 2011
1.3 years
June 22, 2010
December 2, 2011
Conditions
Outcome Measures
Primary Outcomes (2)
Treatment Response
Response is defined as MADRS \<=12 or less than 50% of baseline MADRS (Montgomery Asberg depression rating score).
Week 1
Treatment response
Response defined as above.
Week 2
Study Arms (1)
active stimulation
EXPERIMENTALIn active stimulation, the anode is placed over the left dorsolateral prefrontal cortex and the cathode is placed over the right prefrontal cortex. They are located five centimeters ventrally of the primary motor area, which are located five centimeters laterally of the central point of the scalp (which is located on the intersection of the sagittal and median curves). The device will deliver a charge of 2mA for 30 minutes.
Interventions
Transcranial direct current stimulation will be applied at 2mA, 30 minutes/day, for 10 weekdays consecutively
Eligibility Criteria
You may qualify if:
- Patients from a previous study (ID:USP-HU-001) who:
- received sertraline and did not respond.
- received placebo and did not respond.
You may not qualify if:
- Patients from a previous study who:
- received active tDCS.
- responded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Sao Paulo
São Paulo, São Paulo, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andre R Brunoni, MD
University of Sao Paulo
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- P.I., Research Associate
Study Record Dates
First Submitted
June 22, 2010
First Posted
June 24, 2010
Study Start
June 1, 2010
Primary Completion
September 1, 2011
Study Completion
December 1, 2011
Last Updated
December 6, 2011
Record last verified: 2011-12